Foot DeformityNCT07878000
Subtalar & Talonavicular Arthrodesis v.s Subtalar & Naviculocuniform Arthrodesis for Progressive Collapsing Foot Deformity
A study testing Subtalar and talonavicular arthrodesis and subtalar and naviculocuneiform arthrodesis in people with Foot Deformity and Arthrodesis, run by Cairo University at 1 site in Egypt.
Trial summary
This study compares two surgical procedures for adults with painful, rigid progressive collapsing foot deformity, also known as rigid flatfoot, whose symptoms have persisted despite at least six months of nonsurgical treatment. Both procedures fuse the subtalar joint, a joint below the ankle. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Foot Deformity, Arthrodesis
- What is being tested?
- Subtalar and talonavicular arthrodesis and subtalar and naviculocuneiform arthrodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 20 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: skeletal maturity > 18 yrs
- Sex: Both males and females.
- The patient was diagnosed with rigid pes planovalgus, corresponding to Progressive Collapsing Foot Deformity (PCFD) type 2(ABC) - a rigid Stage II deformity characterized by hindfoot valgus, midfoot abduction, and medial column instability. Under the earlier Johnson and Strom / Myerson classification, this presentation would correspond to Stage III disease, defined by fixed hindfoot valgus and forefoot abduction with degenerative articular change.
- Deformity apex-matched clinical decision (talonavicular apex → ST+TN; naviculocuneiform apex → ST+NC)
Who cannot join
- Skeletally immature patients
- Charcot arthropathy,
- Rheumatoid arthritis.
- Prior surgery at the NC site
- Patients with stage IV PTT dysfunction
- Infection
Show all 9Show fewer
- Asymptomatic patients
- Peripheral vascular disease
- Uncontrolled diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
This study compares two surgical procedures for adults with painful, rigid progressive collapsing foot deformity, also known as rigid flatfoot, whose symptoms have persisted despite at least six months of nonsurgical treatment.
Both procedures fuse the subtalar joint, a joint below the ankle. One procedure also fuses the talonavicular joint, while the other fuses the naviculocuneiform joint. These joints are located at different points along the inner arch of the foot. Joint fusion joins bones together to improve foot alignment and stability. The procedure is selected according to where the foot's inner arch has collapsed.
Read more
The study evaluates changes in foot alignment on standing X-rays, foot and ankle function, physical function, and quality of life. It also compares operating time, bone healing, and complications. Both groups receive the same postoperative care and rehabilitation, with follow-up assessments during recovery and approximately one year after surgery.
The aim is to compare the outcomes of these two surgical approaches when each is selected according to the location of the deformity.
- Conditions
- Foot Deformity, Arthrodesis
- Being tested
- Subtalar and talonavicular arthrodesis, subtalar and naviculocuneiform arthrodesis
- Medical subject headings
- Foot Deformities, Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subtalar and talonavicular arthrodesisProcedure or surgery
Subtalar and talonavicular arthrodesis: Surgical fusion of the subtalar and talonavicular joints to stabilize the hindfoot, correct deformity, and relieve pain.
subtalar and naviculocuneiform arthrodesisProcedure or surgery
Subtalar and naviculocuneiform arthrodesis: Surgical fusion of the subtalar and naviculocuneiform joints to stabilize the foot, correct deformity, and relieve pain.
| Study group | Role | What they receive |
|---|---|---|
| Group A: ST+TN | Active comparator | Subtalar and talonavicular arthrodesis Receives: Procedure: Subtalar and talonavicular arthrodesis |
| Group B: ST+NC | Active comparator | subtalar and naviculocuneiform arthrodesis Receives: Procedure: subtalar and naviculocuneiform arthrodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
AOFAS
The AOFAS ankle-hindfoot score assesses pain, function, and alignment. Scores range from 0 to 100, with higher scores indicating better outcomes. Change is calculated as the postoperative score minus the preoperative score. Mean changes are compared between the subtalar plus talonavicular arthrodesis group and the subtalar plus naviculocuneiform arthrodesis group.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Jan 2025
- Primary completion1 Aug 2026
- Study completion20 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot DeformityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Gamal Reyad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878000
- Sponsor's protocol ID
- collapsing foot deformity
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subtalar & Talonavicular Arthrodesis v.s Subtalar & Naviculocuniform Arthrodesis for Progressive Collapsing Foot Deformity
- ClinicalTrials.gov ID
- NCT07878000
- Acronym / sponsor ID
- collapsing foot deformity
- Conditions
- Foot Deformity, Arthrodesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 20 Aug 2026 (actual)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares two surgical procedures for adults with painful, rigid progressive collapsing foot deformity, also known as rigid flatfoot, whose symptoms have persisted despite at least six months of nonsurgical treatment.
Both procedures fuse the subtalar joint, a joint below the ankle. One procedure also fuses the talonavicular joint, while the other fuses the naviculocuneiform joint. These joints are located at different points along the inner arch of the foot. Joint fusion joins bones together to improve foot alignment and stability. The procedure is selected according to where the foot's inner arch has collapsed.
The study evaluates changes in foot alignment on standing X-rays, foot and ankle function, physical function, and quality of life. It also compares operating time, bone healing, and complications. Both groups receive the same postoperative care and rehabilitation, with follow-up assessments during recovery and approximately one year after surgery.
The aim is to compare the outcomes of these two surgical approaches when each is selected according to the location of the deformity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: ST+TN | Active comparator | Procedure: Subtalar and talonavicular arthrodesisSubtalar and talonavicular arthrodesis |
| Group B: ST+NC | Active comparator | Procedure: subtalar and naviculocuneiform arthrodesissubtalar and naviculocuneiform arthrodesis |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: skeletal maturity > 18 yrs
- Sex: Both males and females.
- The patient was diagnosed with rigid pes planovalgus, corresponding to Progressive Collapsing Foot Deformity (PCFD) type 2(ABC) - a rigid Stage II deformity characterized by hindfoot valgus, midfoot abduction, and medial column instability. Under the earlier Johnson and Strom / Myerson classification, this presentation would correspond to Stage III disease, defined by fixed hindfoot valgus and forefoot abduction with degenerative articular change.
- Deformity apex-matched clinical decision (talonavicular apex → ST+TN; naviculocuneiform apex → ST+NC)
Key exclusion criteria (9 listed)
- Skeletally immature patients
- Charcot arthropathy,
- Rheumatoid arthritis.
- Prior surgery at the NC site
- Patients with stage IV PTT dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subtalar and talonavicular arthrodesisSubtalar and talonavicular arthrodesis: Surgical fusion of the subtalar and talonavicular joints to stabilize the hindfoot, correct deformity, and relieve pain. | Procedure or surgery | Group A: ST+TN |
| subtalar and naviculocuneiform arthrodesisSubtalar and naviculocuneiform arthrodesis: Surgical fusion of the subtalar and naviculocuneiform joints to stabilize the foot, correct deformity, and relieve pain. | Procedure or surgery | Group B: ST+NC |
Primary outcome
AOFAS
Time frame: 1 day
The AOFAS ankle-hindfoot score assesses pain, function, and alignment. Scores range from 0 to 100, with higher scores indicating better outcomes. Change is calculated as the postoperative score minus the preoperative score. Mean changes are compared between the subtalar plus talonavicular arthrodesis group and the subtalar plus naviculocuneiform arthrodesis group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subtalar and talonavicular arthrodesis and subtalar and naviculocuneiform arthrodesis in people with Foot Deformity and Arthrodesis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AOFAS (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.